Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients

Clinique Saint Jean, France

Status: Enrolling

Conditions: Trapeziometacarpal Osteoarthritis

Treatments: Procedure: Isolated trapeziometacarpal arthroplasty with double mobility

Study type: Interventional

Funder types: Other

Identifiers

NCT07169474

TM2025

Details and patient eligibility

About

The aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms.

The primary endpoint is the evolution of the Quick DASH functional score between inclusion (preoperative) and one year postoperatively.

The study design is a follow-up study of a multicenter cohort.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:- Patients over 18 years of age who are members or beneficiaries of french social security

• Patient requiring surgical management
• Clinical and radiographic diagnosis of peri-trapezial osteoarthritis in the 1 or 2 joints:

TM osteoarthritis: glickel sign + grinding test STT osteoarthritis: pain on wrist mobilization in flexion-extension and prono-supination

• TM (Eaton-Littler stages II to III) and STT (Crosby stages II and III) radiographic osteoarthritis
• Persistent pain and functional limitations despite conservative treatment for at least 6 months (combining intermittent immobilization of wrist and thumb + joint infiltration of the 2 joints)
• Ability to understand and sign the informed consent form.

Exclusion Criteria:

• History of surgery on the affected thumb.
• Systemic inflammatory diseases (e.g. rheumatoid arthritis).
• Active infection or history of joint infection of the upper limb.
• Inability to participate in post-operative follow-up.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Isolated trapeziometacarpal arthroplasty

Experimental group

Description:

Isolated TM arthroplasty with double mobility in all cases, using a MAIA (Laboratoire LEPINE) or TOUCH (Laboratoire KERIMEDICAL) prosthesis, depending on the surgeons' habits. Participating surgeons will follow a common operating protocol to ensure consistency of procedures.

Treatment:

Procedure: Isolated trapeziometacarpal arthroplasty with double mobility